Drugs

Alvogen Recalls 7 Clindamycin Lots Over Sterility Issues

Alvogen has recalled seven lots of clindamycin injection USP ADD-Vantage Vials due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. The drug is indicated for treating serious infections caused by susceptible bacteria. Its use should be reserved for penicillin-allergic patients or other patients for whom penicillin is inappropriate. The product is manufactured for Alvogen by Pfizer’s Hospira drug unit.

“In the event that impacted product is administered, there is a reasonable probability that the patient may experience adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis,” an FDA recall notice says. “The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. To date, Alvogen has not received any reports of adverse events associated with use of the product.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome